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Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude

This study has been completed.
Sponsor:
Collaborator:
MVZ für Laboratoriumsmedizin Koblenz
Information provided by (Responsible Party):
Andree Hillebrecht, University of Giessen
ClinicalTrials.gov Identifier:
NCT01468194
First received: October 9, 2011
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  Purpose
In this investigation the researchers explore whether different types of breathing procedures can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain sickness or a high altitude pulmonary edema.

Condition Intervention
Acute Mountain Sickness
 Other: Breathing procedure 1
Other: Breathing procedure 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • change of peripheral oxygen saturation [ Time Frame: immediate after intervention ] [ Designated as safety issue: No ]
    change of peripheral oxygen saturation under different breathing procedures in different altitudes


Secondary Outcome Measures:
  • change of breathing parameters [ Time Frame: immediate after intervention ] [ Designated as safety issue: No ]

    change of breathing parameters under different breathing procedures in different altitudes

    • breathing rate
    • minute ventilation
    • expiratory end-tidal CO2-partial pressure

  • change of cognition [ Time Frame: immediate after intervention ] [ Designated as safety issue: No ]
    change of ability of cognition (measured by d2-test) under different breathing procedures in different altitudes
Estimated Enrollment: 30
Study Start Date: July 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breathing procedure 1
Walking with breathing procedure "1".
 Other: Breathing procedure 1
inhalation during one step, exhalation during the next step
Experimental: Breathing procedure 2
Walking with breathing procedure "2".
 Other: Breathing procedure 2
inhalation and exhalation during one step
No Intervention: Control group
Walking without any reglementation of breathing

Detailed Description:

Acute mountain sickness (AMS) is a pathological effect of high altitude on humans caused by acute exposure to low partial pressure of oxygen at high altitude. It commonly occurs above 2500 meters of altitude. AMS appears as a collection of nonspecific symptoms acquired at high altitude or in low air pressure resembling a case of "flu, carbon monoxide poisoning, or a hangover".

It is caused by a drop in pressure and lowering partial pressure of oxygen during increasing altitude. The direct consequence of those changes is a hypoxic pulmonary vasoconstriction (Euler-Lijestrand-mechanism). In addition a rise in pulmonary blood pressure (Hypertonia) can occur so that there is a higher risk of developing a high altitude pulmonary edema (HAPE).

In this investigation the investigators are exploring whether different types of breathing procedures can improve the peripheral oxygen saturation. We are comparing breathing with no regulation with two different procedures of hyperventilation during trekking in different altitudes. Procedure 1 (hyperventilation 1) describes inhalation during one step and exhalation during the next step. Procedure 2 (hyperventilation 2) describes inhalation and exhalation during one step.

The effect of the different breathing procedures can be quantified measuring the peripheral oxygen saturation. In addition the investigators are comparing the breathing rate and the minute ventilation as well as the expiratory end-tidal CO2-partial pressure of the three different breathing procedures.

Furthermore, the investigators are examining the ability to concentrate in order to quantify the effect of AMS on organ functions.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Exclusion Criteria:

  • acute clinically significant inter-current diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468194

Locations
Germany
University of Giessen
Giessen, Hessen, Germany, 35394
Sponsors and Collaborators
University of Giessen
MVZ für Laboratoriumsmedizin Koblenz
Investigators
Principal Investigator: Gabor Szalay, Dr. med. Trauma surgery - University hospital Giessen
  More Information

Responsible Party: Andree Hillebrecht, Akademischer Rat, University of Giessen
ClinicalTrials.gov Identifier: NCT01468194     History of Changes
Other Study ID Numbers: Gi-04-2011 
Study First Received: October 9, 2011
Last Updated: November 8, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Giessen:
AMS
HAPE
high altitude
oxygen
 saturation
mountain
climbing
breathing

Additional relevant MeSH terms:
Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 26, 2016